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- Responsible for writing and ensuring all communications are complete and scientifically accurate
- Accountable for preparation of accurate, timely regulatory documents submitted to regulatory agencies worldwide
- Responsible for managing writing activities across assigned projects to ensure medical writing strategy adherence
- Serve as medical writing expert and contribute to therapeutic project teams for clinical and regulatory submission documents
- Authors deliverables with consideration for regulatory, departmental, and quality standards (documents include protocols, clinical study reports, annual reports, Investigator's Brochures [IBs], integrated data summary reports, Health Authority briefing packages and response documents, and submission summary modules)
- Have strong understand of medical writing practices, tools and systems to support clinical studies, to meet company objectives
- Ensure standardized practices are implemented across all therapeutic areas
- Minimum of a BA/BS in Life Science; graduate degree preferred
- 4-7 years pharmaceutical/biotechnology experience related to clinical research
- Experienced writing/developing clinical documents to support global regulatory submissions
- Medical writing experience in Pharma, Biotech and/or CRO environment
- Medical device experience preferred but not required
- BA/BS degree – seeking 7+ years of writing experience or MS/PhD degree– seeking 4+ years of writing experience
- MS Office Proficiency
- Experience with electronic submission and ICH guidelines for regulatory reports
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Medical Writer - Princeton, United States - Clinical Resource Network (CRN)
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Description
Our client is looking to fill the role of a Medical Writer. This position will be fully remote.
Responsibilities:
Required Qualifications:
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
